Yale Journal of Health Policy, Law, and Ethics

Current Issue: Volume 22, Issue 1

The Patient's Voice: Legal Implications of Patient-Reported Outcome Measures

Sharona Hoffman and Andy Podgurski

In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.

Patient-reported outcome measures (PROMs) are reports of patients' symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic questionnaires. In this era of growing efforts to control health care costs, improve care delivery, and combat physician burnout, patients' own input can be invaluable for clinicians as well as researchers, regulators, and insurers. At the same time, however, PROMs have several pitfalls, and the implementation of PROM programs is challenging and complex.

The article argues that health care providers should be keenly aware of potential medical malpractice risks associated with PROMs. In addition, because PROMs collect a plethora of sensitive information about pain, sexual function, anxiety, and other matters, the HIPAA Privacy Rule should be revised to address PROMs specifically. The Article further posits that it would be premature for regulatory agencies or private insurers to require PROM submission at this time. It also details strategies, such as use of artificial intelligence, to strengthen PROMs and facilitate their integration into clinical practice and other arenas.

Back to Bakke: The Compelling Need for Diversity in Medical School Admissions

Justin Cole and Gregory Curfman

In Supreme Court cases involving affirmative action in university admissions prior to 2023, most notably Bakke and Grutter, the Court upheld the constitutionality of race-based admissions on the basis of the diversity rationale. This rationale contends that racial and ethnic diversity in university classrooms benefits the education of all students, regardless of their race or ethnicity. Now, though, the Court has effectively overturned decades of precedent in deciding Students for Fair Admissions, Inc. v. President & Fellows of Harvard College and Students for Fair Admissions, Inc. v. University of North Carolina.

This Article examines the diversity rationale going back to Bakke and proceeding all the way to the recent decision in Students for Fair Admissions. We concede the weaknesses of the diversity rationale, which, along with the purported lack of reliance interests since Grutter, contributed to the Court ending affirmative action nationwide. Yet we maintain that diversity in the context of medical school admissions should be viewed as a compelling interest for the purposes of equal protection analysis given the significant benefits of a diverse physician workforce to the health care system, particularly in the context of providing quality care to historically marginalized groups. We conclude by identifying a few possible paths forward now that the Court has deemed affirmative action unlawful nationwide.

The Fall of FDA Review

Daniel G. Aaron

The U.S. Food and Drug Administration (FDA) is in crisis. FDA can hardly go a single day without an investigation, negative news story, or scholarly critique of the agency's work. We have increasingly entrusted FDA—today, to the tune of 25% of the U.S. economy—with vetting the products we put in and on our bodies. But the array of problems facing the agency raises questions about whether it is equipped to succeed in the 21st century.

FDA's core function is to oversee a special legal regime called "premarket review." Congress has prohibited all marketing of certain types of products (like drugs) until FDA reviews and approves an application from the manufacturer. This system allows consumers to depend on the foods they ingest, the pills they swallow, and the health care they receive—in theory. But critics have documented how FDA review failures have produced, or contributed to, public health crises, including those related to opioids, e-cigarettes, trans fats, sugar, and, most recently, the COVID-19 pandemic.

Leveraging five FDA product areas, this Article argues that premarket review is faltering. The reasons vary somewhat across FDA's regulatory regimes. However, the bottom line is the same: longstanding efforts to undermine FDA governance by corporations and financial power writ large. Corporate deregulatory efforts have operated through courts, Congress, the President, and the agency's leadership itself. In some cases, premarket review has been so hollowed out that all that remains is the illusion of regulation, nothing more. These developments reflect the ascendancy of neoliberalism, a system in which core social guarantees devolve to decisions by individual consumers.

We need not accept this state of affairs. Learning from the mechanisms behind premarket review's erosion, this Article proposes a suite of structural solutions to build a revitalized FDA: one that is dutifully empowered, inside and out, to safeguard the public health.